Over the past several decades thousands of patients have been fitted with implantable cardiac pacing, cardioversion, defibrillation and/or other devices that can deliver cardiac therapy. Monitoring of such patients often involves a collaborative effort of physicians, nurses, device manufacturers, regulatory agencies, insurance companies and health care institution managers. Patients may receive care through in-person office visits, telephone consultations or other communication routes (e.g., the Internet, etc.). Care is often scheduled on a periodic basis, although office visits may occur less frequently than distance consultations (e.g., typically at least four times per year). During an office or a distance consultation, automated analyses may be performed in which an implanted device communicates with a receiver and/or transmitter unit, which is typically connected to a computer. Aside from such procedures, little else involving patient care is automated. For example, care providers typically need to follow extensive written guidelines on how to assess a patient's condition and/or the condition of an implanted device (e.g., follow-up guidelines). Further, information collected by a care provider typically requires performance of certain assessments and associated data entry during and/or after a consultation. Such assessments require a substantial time commitment and patient care provider interaction. Further, the associated data entry can require a significant amount of care provider time.
One such assessment involves the patient care provider verifying device programming and functionality by performing a series of tests utilizing the device and the programmer after the device has been implanted in the patient. These tests include measuring amplitudes of intrinsic cardiac events, such as P-waves, naturally occurring in the patient's heart as well as capture thresholds of pacing pulses required to generate a cardiac response. These tests are time consuming.
Such tests take time in the clinic because the physician has to observe the test being performed, and then analyze and print the results, which include intracardiac electrograms. The physician receives a result, such as, for example, a P-wave amplitude in the form of a numeric value, and also is able to see the events used to obtain that result via real-time markers and electrograms.
To verify the validity of the test data measured by the device, the physician retrieves the test data from the device, generates intracardiac electrograms of the patient's heart, and compares the test data with the intracardiac electrograms. For example, the physician may examine the intracardiac electrogram to verify the morphology of a cardiac event and to determine whether the test data corresponds to the cardiac event.
One possible way to reduce the time spent by the physician is to make these same measurements outside the clinic. The pacemaker can perform measurements outside the clinic and store the numerical results in the pacemaker for later viewing by the physician. Currently, with an outside the clinic measurement, when the physician interrogates the device, a numerical result is provided. For example, the result may indicate that the ventricular capture threshold is 0.875 V. Since the measurement was made while the patient was away from the clinic, the electrogram and marker data for the events used to obtain these measurements is not available. As such, the physician is not able to assess whether the events measured were truly P-waves, or to have printouts of the measured events available for inclusion in the patient's record.
In light of the above, a need exists for collection and/or analysis of automatically generated test data from an intracardiac stimulation device that allows a patient care provider to verify the test data in a time efficient manner.